Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer
Primary Purpose
Hypopharyngeal Cancer, Immunotherapy, Induction Chemotherapy
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Hypopharyngeal Cancer
Eligibility Criteria
Inclusion Criteria:
- Age: 18-75 years;
- Hypopharyngeal squamous cell carcinoma confirmed by histopathology;
- No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system );
- At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been treated;
- Provide tissues for biomarker analysis;
- ECOG PS 0-1;
- Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN at diagnosis or after biliary drainage, ALT and AST < 5×ULN, BUN、CREA<1.5×ULN, creatinine clearance rate ≥ 45ml/min;
- Contraception during the study;
- At least 12 weeks of life expectancy;
- Willing to join the study and sign informed consent.
Exclusion Criteria:
- Allergic to any component of carrelizumab, cisplatin and other platinum drugs;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy in the past;
- Received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment;
- Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer;
- Have corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting;
- Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 1 year;
- Have severe infections (CTCAE> Grade 2) occurred within 4 weeks before the first use of the study drug;
- Have active autoimmune diseases, autoimmune diseases, but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes with stable doses of insulin; vitiligo or cured childhood asthma/allergies;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
- A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia;
- Active tuberculosis, having antituberculosis therapy at present or within 1 year;
- Have active hepatitis B (HBV DNA ≥2000 IU/mL or 10~4 copies/mL) and hepatitis C;
- Have other uncontrollable comorbidities;
- Knowing a history of psychotropic drug abuse, alcohol or drug abuse;
- Pregnant or breastfeeding, or expect to become pregnant during the clinical trial period.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
induction chemotherapy + anti-PD-1 antibody
Arm Description
Camrelizumab (200 mg, Q3w, 2 cycles in total) combined with induction chemotherapy (taxane-containing regimen, Q3w, 2 cycles in total) followed by concurrent radiotherapy and chemotherapy.
Outcomes
Primary Outcome Measures
Progression-free Survival, PFS
Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Secondary Outcome Measures
Objective Response Rate (ORR)
Defined as the portion of patients with a tumor size reduction of a predefined amount for a minimum time period. Tumor response will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
Duration of Response(DoR)
Response duration is measured from the time of initial response until documented tumor progression.
Disease Control Rate (DCR)
Refers to the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD).
Overall Survival (OS)
Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Adverse events (AE)
Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Full Information
NCT ID
NCT04539600
First Posted
September 1, 2020
Last Updated
August 14, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04539600
Brief Title
Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer
Official Title
Induction Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Locoregionally Advanced Hypopharyngeal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 12, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is a single center phase II trial. The purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-PD-1 antibody Followed by chemoradiotherapy in locoregionally advanced hypopharyngeal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopharyngeal Cancer, Immunotherapy, Induction Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
induction chemotherapy + anti-PD-1 antibody
Arm Type
Experimental
Arm Description
Camrelizumab (200 mg, Q3w, 2 cycles in total) combined with induction chemotherapy (taxane-containing regimen, Q3w, 2 cycles in total) followed by concurrent radiotherapy and chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
Camrelizumab is a type of anti-PD-1 antibody that could enhance the immune system of the patient to fight cancer.
Primary Outcome Measure Information:
Title
Progression-free Survival, PFS
Description
Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Defined as the portion of patients with a tumor size reduction of a predefined amount for a minimum time period. Tumor response will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
Time Frame
1 year
Title
Duration of Response(DoR)
Description
Response duration is measured from the time of initial response until documented tumor progression.
Time Frame
1 year
Title
Disease Control Rate (DCR)
Description
Refers to the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD).
Time Frame
1 year
Title
Overall Survival (OS)
Description
Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Time Frame
1 year
Title
Adverse events (AE)
Description
Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-75 years;
Hypopharyngeal squamous cell carcinoma confirmed by histopathology;
No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system );
At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been treated;
Provide tissues for biomarker analysis;
ECOG PS 0-1;
Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN at diagnosis or after biliary drainage, ALT and AST < 5×ULN, BUN、CREA<1.5×ULN, creatinine clearance rate ≥ 45ml/min;
Contraception during the study;
At least 12 weeks of life expectancy;
Willing to join the study and sign informed consent.
Exclusion Criteria:
Allergic to any component of carrelizumab, cisplatin and other platinum drugs;
Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy in the past;
Received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment;
Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer;
Have corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting;
Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 1 year;
Have severe infections (CTCAE> Grade 2) occurred within 4 weeks before the first use of the study drug;
Have active autoimmune diseases, autoimmune diseases, but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes with stable doses of insulin; vitiligo or cured childhood asthma/allergies;
A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia;
Active tuberculosis, having antituberculosis therapy at present or within 1 year;
Have active hepatitis B (HBV DNA ≥2000 IU/mL or 10~4 copies/mL) and hepatitis C;
Have other uncontrollable comorbidities;
Knowing a history of psychotropic drug abuse, alcohol or drug abuse;
Pregnant or breastfeeding, or expect to become pregnant during the clinical trial period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Wu, doctor
Phone
+862087755766
Email
wush77@mail.sysu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuang Wu
Phone
+862087755766
Email
wush77@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer
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